FDA Drug recall D-0368-2025
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boo…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boo… by Amerisource Health Services, citing lack of assurance of sterility. Bacterial contamination detected in some media fill units.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0368-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-02 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
Reason
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Identifiers
| ndc | 68001-579-59 |
|---|---|
| ndc | 68001-579-48 |
| ndc | 68001-580-41 |
| ndc | 68001-581-41 |
| ndc | 68001-581-48 |
| ndc | 68001-581-82 |
| ndc | 68001-578-59 |
| ndc | 68001-578-48 |
| ndc | 68001-582-41 |
| code_info | A240482A, EXP 08/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0368-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.